Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2011-004660-30 | EudraCT Number | EudraCT |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary objective of this trial is to investigate the effect of 6 weeks treatment with tiotropium + olodaterol fixed dose combination inhalation solution on lung hyperinflation and exercise tolerance in patients with COPD.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Olodaterol 5 mcg QD | Active Comparator | patient will receive olodaterol 5 mcg once daily |
|
| Placebo QD | Placebo Comparator | placebo comparator for tiotropium + olodaterol |
|
| Tiotropium 5 mcg QD | Active Comparator | patient will receive tiotropium 5 mcg once daily |
|
| Tiotropium + olodaterol low dose QD | Experimental | patient will receive tiotropium 2.5 mcg + olodaterol 5 mcg in fixed dose combination once daily |
|
| Tiotropium + olodaterol high dose | Experimental | patient will receive tiotropium 5 mcg + olodaterol 5 mcg in fixed dose combination once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | placebo matching tiotropium + olodaterol |
| |
| Tiotropium + Olodaterol |
| Measure | Description | Time Frame |
|---|---|---|
| Inspiratory Capacity at Rest Before Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Work Capacity | Inspiratory capacity (IC) at rest before constant work rate cycle ergometry to symptom limitation at 75% maximal work capacity (Wcap). Wcap was defined as the maximum work rate achieved for at least 30 seconds during the incremental cycle ergometry performed at Visit 1. The presented means are adjusted means from the MMRM (Mixed Effects Model Repeated Measures) model. | 6 weeks |
| Endurance Time During Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Wcap | Endurance time during constant work rate cycle ergometry (CWRCE) to symptom limitation at 75% Wcap Wcap was defined as the maximum work rate achieved for at least 30 seconds during the incremental cycle ergometry performed at Visit 1. The presented means are adjusted mean from the MMRM model. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Slope of the Intensity of Breathing Discomfort (Borg Scale) During Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Wcap | Slope of the intensity of breathing discomfort (Borg Scale) during CWRCE to symptom limitation at 75% Wcap. The intensity of breathing discomfort was rated using the modified Borg scale with ratings from 0 (nothing at all) to 10 (maximal). Slope is defined as : (intensity of breathing discomfort at the end of exercise minus intensity of breathing discomfort at rest) / endurance time. A decrease in slope indicates improvement. The presented means are adjusted means from MMRM model. |
Not provided
Inclusion criteria:
All patients must sign an informed consent consistent with ICH-GCP guidelines prior to participation in the trial, which includes medication washout and restrictions.
All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria:
Patients must have relatively stable airway obstruction with a post-bronchodilator FEV1 <80% of predicted normal and a post-bronchodilator FEV1/FVC <70% at Visit 1.
Male or female patients, between 40 and 75 years of age (inclusive) on day of signing informed consent.
Patients must be current or ex-smokers with a smoking history of more than 10 pack years.
Exclusion criteria:
Patients with a significant disease other than COPD; a significant disease is defined as a disease which, in the opinion of the investigator, may (i) put the patient at risk because of participation in the study, (ii) influence the results of the study, or (iii) cause concern regarding the patient's ability to participate in the study
Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis; all patients with an SGOT >x2 ULN, SGPT >x2 ULN, bilirubin >x2 ULN or creatinine >x2 ULN will be excluded regardless of clinical condition
Patients with a history of asthma. For patients with allergic rhinitis or atopy, source documentation is required to verify that the patient does not have asthma.
Patients with any of the following conditions:
A diagnosis of thyrotoxicosis (due to the known class side effect profile of ß2-agonists)
A diagnosis of paroxysmal tachycardia (>100 beats per minute) (due to the known class side effect profile of ß2-agonists)
A history of myocardial infarction within 1 year of screening visit (Visit 1)
Unstable or life-threatening cardiac arrhythmia
Hospitalized for heart failure within the past year
Known active tuberculosis
A malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years (patients with treated basal cell carcinoma are allowed)
A history of life-threatening pulmonary obstruction
A history of cystic fibrosis
Clinically evident bronchiectasis
A history of significant alcohol or drug abuse
Any contraindications for exercise testing.
Patients who have undergone thoracotomy with pulmonary resection (patients with a history of thoracotomy for other reasons should be evaluated as per exclusion criterion No. 1)
Patients being treated with any oral ß-adrenergics
Patients being treated with oral corticosteroid medication at unstable doses
Patients who regularly use daytime oxygen therapy for more than one hour per day and in the investigator's opinion will be unable to abstain from the use of oxygen therapy during clinic visits
Patients who have completed a pulmonary rehabilitation program in the six weeks prior to the screening visit or patients who are currently in a pulmonary rehabilitation program
Patients who have a limitation of exercise performance as a result of factors other than fatigue or exertional dyspnoea, such as arthritis in the leg, angina pectoris or claudication or morbid obesity.
Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to screening visit
Patients with known hypersensitivity to ß-adrenergics drugs, anticholinergic drugs, BAC, EDTA or any other component of the Respimat® inhalation solution delivery system
Pregnant or nursing women
Women of childbearing potential not using highly effective methods of birth control.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1237.14.01404 Boehringer Ingelheim Investigational Site | Phoenix | Arizona | United States | |||
| 1237.14.01414 Boehringer Ingelheim Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28424359 | Derived | O'Donnell DE, Casaburi R, Frith P, Kirsten A, De Sousa D, Hamilton A, Xue W, Maltais F. Effects of combined tiotropium/olodaterol on inspiratory capacity and exercise endurance in COPD. Eur Respir J. 2017 Apr 19;49(4):1601348. doi: 10.1183/13993003.01348-2016. Print 2017 Apr. |
Not provided
Not provided
This was a randomised, 4-period incomplete block cross-over trial. 291 patients were randomized to one of five treatments sequences and treated. It was a double-blind trial in which each treatment period lasted 6 weeks with a washout period of 21 days between each.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Tio+Olo 2.5/5 / Tio+Olo 5/5 / Tio / Olo | Patients received a total of four treatments, and each treatment period is separated by a washout period of 21 days. The treatments administered, by oral inhalation delivered once daily in the morning, via the respimat inhaler, were
|
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Tiotropium 2.5 mcg + olodaterol 5 mcg once daily |
|
| tiotropium + Olodaterol | Drug | tiotropium 5 mcg + olodaterol 5 mcg once daily |
|
| Tiotropium | Drug | tiotropium |
|
| Olodaterol | Drug | Olodaterol 5 mcg once daily |
|
| Respimat | Device | Respimat inhaler |
|
| 6 weeks |
| FEV1 (1 Hour Post-dose) | Forced Expiratory Volume in 1 Second (FEV1) (one hour post-dose). The presented means are adjusted means from MMRM model. | 6 weeks |
| Austell |
| Georgia |
| United States |
| 1237.14.01417 Boehringer Ingelheim Investigational Site | Baltimore | Maryland | United States |
| 1237.14.01418 Boehringer Ingelheim Investigational Site | Rochester | Minnesota | United States |
| 1237.14.01408 Boehringer Ingelheim Investigational Site | Saint Charles | Missouri | United States |
| 1237.14.01409 Boehringer Ingelheim Investigational Site | Charlotte | North Carolina | United States |
| 1237.14.01407 Boehringer Ingelheim Investigational Site | Greenville | South Carolina | United States |
| 1237.14.01403 Boehringer Ingelheim Investigational Site | Spartanburg | South Carolina | United States |
| 1237.14.01401 Boehringer Ingelheim Investigational Site | Union | South Carolina | United States |
| 1237.14.01412 Boehringer Ingelheim Investigational Site | Dallas | Texas | United States |
| 1237.14.01410 Boehringer Ingelheim Investigational Site | Seattle | Washington | United States |
| 1237.14.54402 Boehringer Ingelheim Investigational Site | Buenos Aires | Argentina |
| 1237.14.54401 Boehringer Ingelheim Investigational Site | Mendoza | Argentina |
| 1237.14.43402 Boehringer Ingelheim Investigational Site | Grieskirchen | Austria |
| 1237.14.43401 Boehringer Ingelheim Investigational Site | Neumarkt am Wallersee | Austria |
| 1237.14.11404 Boehringer Ingelheim Investigational Site | Vancouver | British Columbia | Canada |
| 1237.14.11403 Boehringer Ingelheim Investigational Site | Toronto | Ontario | Canada |
| 1237.14.11402 Boehringer Ingelheim Investigational Site | Montreal | Quebec | Canada |
| 1237.14.11401 Boehringer Ingelheim Investigational Site | Ste-Foy | Quebec | Canada |
| 1237.14.49406 Boehringer Ingelheim Investigational Site | Bamberg | Germany |
| 1237.14.49404 Boehringer Ingelheim Investigational Site | Bochum | Germany |
| 1237.14.49401 Boehringer Ingelheim Investigational Site | Großhansdorf | Germany |
| 1237.14.49405 Boehringer Ingelheim Investigational Site | Hamburg | Germany |
| 1237.14.49403 Boehringer Ingelheim Investigational Site | Hanover | Germany |
| 1237.14.49402 Boehringer Ingelheim Investigational Site | Kiel | Germany |
| 1237.14.31001 Boehringer Ingelheim Investigational Site | Heerlen | Netherlands |
| 1237.14.31005 Boehringer Ingelheim Investigational Site | Hoofddorp | Netherlands |
| 1237.14.31004 Boehringer Ingelheim Investigational Site | Hoorn | Netherlands |
| 1237.14.31006 Medisch Centrum Leeuwarden | Leeuwarden | Netherlands |
| 1237.14.31007 Boehringer Ingelheim Investigational Site | Leiden | Netherlands |
| 1237.14.70401 Boehringer Ingelheim Investigational Site | Moscow | Russia |
| 1237.14.70402 Boehringer Ingelheim Investigational Site | Saint Petersburg | Russia |
| 1237.14.46001 Boehringer Ingelheim Investigational Site | Lund | Sweden |
| FG001 | Tio+Olo 5/5 / Tio / Olo / Placebo | Patients received a total of four treatments, and each treatment period is separated by a washout period of 21 days. The treatments administered, by oral inhalation delivered once daily in the morning, via the respimat inhaler, were
|
| FG002 | Tio / Olo / Placebo / Tio+Olo 2.5/5 | Patients received a total of four treatments, and each treatment period is separated by a washout period of 21 days. The treatments administered, by oral inhalation delivered once daily in the morning, via the respimat inhaler, were
|
| FG003 | Olo / Placebo / Tio+Olo 2.5/5 / Tio+Olo 5/5 | Patients received a total of four treatments, and each treatment period is separated by a washout period of 21 days. The treatments administered, by oral inhalation delivered once daily in the morning, via the respimat inhaler, were
|
| FG004 | Placebo / Tio+Olo 2.5/5 / Tio+Olo 5/5 / Tio | Patients received a total of four treatments, and each treatment period is separated by a washout period of 21 days. The treatments administered, by oral inhalation delivered once daily in the morning, via the respimat inhaler, were
|
| Received Placebo |
|
| Received Olo 5 |
|
| Received Tio 5 |
|
| Received Tio+Olo 2.5/5 |
|
| Received Tio+Olo 5/5 |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Treated Set (TS) : This patient set included all patients of the Randomised Set (RS : patients who signed the informed consent form and were also randomised, regardless of whether the patient was treated with study medication or not) who were dispensed study medication and were documented to have taken at least 1 dose of study medication.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | A randomised, double-blind, placebo controlled, 5 treatment, 4-period, incomplete, crossover study. Each treatment period was separated by a washout period of 21 days. The treatments administered, by oral inhalation delivered once daily in the morning, via the respimat inhaler, were:
Treatment sequence is not considered as a factor which may affect the treatment effect due to sufficient washout period added between treatment cycles. As a result, we only display baseline characteristics as a whole population, but not by treatment sequence |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Inspiratory Capacity at Rest Before Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Work Capacity | Inspiratory capacity (IC) at rest before constant work rate cycle ergometry to symptom limitation at 75% maximal work capacity (Wcap). Wcap was defined as the maximum work rate achieved for at least 30 seconds during the incremental cycle ergometry performed at Visit 1. The presented means are adjusted means from the MMRM (Mixed Effects Model Repeated Measures) model. | Full Analysis Set (FAS) : This patient set included all patients in the TS who had the study baseline and at least 1 evaluable post-dose measurement for 1 of the primary endpoints. Assignment to the FAS was done after implementation of any data handling rules,which set measurements to missing. | Posted | Mean | Standard Error | Litres | 6 weeks |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Endurance Time During Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Wcap | Endurance time during constant work rate cycle ergometry (CWRCE) to symptom limitation at 75% Wcap Wcap was defined as the maximum work rate achieved for at least 30 seconds during the incremental cycle ergometry performed at Visit 1. The presented means are adjusted mean from the MMRM model. | FAS | Posted | Geometric Mean | Standard Error | seconds | 6 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Slope of the Intensity of Breathing Discomfort (Borg Scale) During Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Wcap | Slope of the intensity of breathing discomfort (Borg Scale) during CWRCE to symptom limitation at 75% Wcap. The intensity of breathing discomfort was rated using the modified Borg scale with ratings from 0 (nothing at all) to 10 (maximal). Slope is defined as : (intensity of breathing discomfort at the end of exercise minus intensity of breathing discomfort at rest) / endurance time. A decrease in slope indicates improvement. The presented means are adjusted means from MMRM model. | FAS | Posted | Mean | Standard Error | units on a scale / s | 6 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | FEV1 (1 Hour Post-dose) | Forced Expiratory Volume in 1 Second (FEV1) (one hour post-dose). The presented means are adjusted means from MMRM model. | All patients in FAS with available FEV1 data at baseline and week 6 are included in the analysis. | Posted | Mean | Standard Error | Litres | 6 weeks |
|
From drug administration until 21 days after the last administration, up to 139 days
One patient received treatment for 118 days, rather than 6 weeks, due to non-compliance with study visit requirements.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Oral inhalation of placebo, 2 puffs from the Respimat inhaler, once daily, in the morning. | 3 | 214 | 41 | 214 | ||
| EG001 | Olodaterol 5 µg | Oral inhalation of Olodaterol fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. | 3 | 218 | 42 | 218 | ||
| EG002 | Tiotropium 5 µg | Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. | 8 | 218 | 48 | 218 | ||
| EG003 | Tiotropium + Olodaterol 2.5/5 | Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. | 3 | 219 | 36 | 219 | ||
| EG004 | Tiotropium + Olodaterol 5/5 | Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. | 4 | 224 | 40 | 224 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Sick sinus syndrome | Cardiac disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Death | General disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Pain | General disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Acute tonsillitis | Infections and infestations | MEDDRA 16.1 | Systematic Assessment |
| |
| Cellulitis gangrenous | Infections and infestations | MEDDRA 16.1 | Systematic Assessment |
| |
| Infective exacerbation of chronic obstructive airways disease | Infections and infestations | MEDDRA 16.1 | Systematic Assessment |
| |
| Parainfluenzae virus infection | Infections and infestations | MEDDRA 16.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MEDDRA 16.1 | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MEDDRA 16.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MEDDRA 16.1 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MEDDRA 16.1 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MEDDRA 16.1 | Systematic Assessment |
| |
| Gastric neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 16.1 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 16.1 | Systematic Assessment |
| |
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 16.1 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MEDDRA 16.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MEDDRA 16.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.1 | Systematic Assessment |
|
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000611386 | tiotropium-olodaterol |
| D000069447 | Tiotropium Bromide |
| C549647 | olodaterol |
| ID | Term |
|---|---|
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
Not provided
Not provided
| Mixed Models Analysis |
| 0.0015 |
| Mean Difference (Final Values) |
| 0.080 |
| Standard Error of the Mean |
| 0.025 |
| 2-Sided |
| 95 |
| 0.031 |
| 0.129 |
Difference calculated as Tiotropium + olodaterol 5/5 QD minus Olodaterol 5 mcg QD |
| No |
| Superiority or Other |
| Mixed Models Analysis | 0.0005 | Mean Difference (Final Values) | 0.088 | Standard Error of the Mean | 0.025 | 2-Sided | 95 | 0.039 | 0.137 | Difference calculated as Tiotropium + olodaterol 5/5 QD minus Tiotropium 5 mcg QD | No | Superiority or Other |
| Mixed Models Analysis | <0.0001 | Mean Difference (Final Values) | 0.274 | Standard Error of the Mean | 0.025 | 2-Sided | 95 | 0.224 | 0.324 | Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Placebo QD | No | Superiority or Other |
| Mixed Models Analysis | 0.0004 | Mean Difference (Final Values) | 0.089 | Standard Error of the Mean | 0.025 | 2-Sided | 95 | 0.039 | 0.138 | Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Olodaterol 5 mcg QD | No | Superiority or Other |
| Mixed Models Analysis | 0.0001 | Mean Difference (Final Values) | 0.097 | Standard Error of the Mean | 0.025 | 2-Sided | 95 | 0.047 | 0.147 | Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Tiotropium 5 mcg QD | No | Superiority or Other |
| OG004 | Tiotropium + Olodaterol 5/5 | Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. |
|
|
|
| OG003 |
| Tiotropium + Olodaterol 2.5/5 |
Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. |
| OG004 | Tiotropium + Olodaterol 5/5 | Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. |
|
|
|
| OG004 | Tiotropium + Olodaterol 5/5 | Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. |
|
|
|